MEISER FELIX,RUSSELL ADRIAN,NORRET MARCK,DODD AARON,BOSCH H WILLIAM
申请号：
NZ62180210
公开号：
NZ621802A
申请日:
2010.04.23
申请国别(地区):
NZ
年份:
2016
代理人:
摘要：
The disclosure relates to a solid unit dosage form comprising 5 mg, 7.5 mg, 10 mg or 15 mg of meloxicam wherein the dosage form further comprises a surfactant, wherein the dosage form further comprises at least one of: lactose monohydrate, anhydrous lactose or mannitol, wherein the particles of meloxicam have an average particle size, determined on a particle number basis, or a median particle size, determined on a particle volume basis, no smaller than 25 nm and no larger than 500nm, wherein the dissolution rate of the unit dosage form is such that when tested using USP Apparatus II (paddles) set to rotation speed of 50 RPM in 500 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37°C±0.5°C, at least 86% of the meloxicam dissolves in 30 minutes, and wherein a single dose, upon oral administration to a population of healthy adults in the fasted state, provides a mean blood plasma Cmax of equal to or greater than 800 ng/ml.
